DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35- avobenzone,homosalate,octisalate,octocrylene cream

DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35 by

Drug Labeling and Warnings

DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., Estee Lauder Cosmetics Ltd, Estee Lauder Cosmetics Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

AVOBENZONE 3%

HOMOSALATE 7%

OCTISALATE 4.5%

OCTOCRYLENE 5%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• For sunscreen use:
• apply liberally 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m.–2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive Ingredients

water\aqua\eau,glycerin,butylene glycol,phenyl trimethicone,butyloctyl salicylate,peg-100 stearate,silica,silica silylate,hydrogenated lecithin,dextrin palmitate,sodium hyaluronate,biosaccharide gum-1,caprylyl glycol,cetearyl alcohol,potassium cetyl phosphate,hexylene glycol,tromethamine,triacontanyl pvp,carbomer,stearyl alcohol,dehydroxanthan gum,disodium edta,phenoxyethanol,potassium sorbate,red 33 (ci 17200),yellow 5 (ci 19140),yellow 6 (ci 15985) <iln53527>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

CLINIQUE

dramatically different

moisturizing loition +

broad spectrum

SPF35

VERY DRY TO DRY COMBINATION

2.5FL.OZ.LIQ./75 ml

INGREDIENTS AND APPEARANCE

DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35 
avobenzone,homosalate,octisalate,octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TROMETHAMINE (UNII: 023C2WHX2V)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
CARBOMER (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIACONTANYL PVP (UNII: N0SS3Q238D)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PEG-100 STEARATE (UNII: YD01N1999R)
SILICA (UNII: ETJ7Z6XBU4)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-222-01	1 in 1 CARTON	03/31/2025
1		75 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49527-222-02	1 in 1 CARTON	03/31/2025
2		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/31/2025

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd		202952982	manufacture(49527-222)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		204132062	pack(49527-222) , label(49527-222)